PATHWORK DIAGNOSTICS TISSUE OF ORIGIN TEST
FDA 510(k) clearance K080896 · decided 2008-07-30
Clearance details
- K-number
- K080896
- Device name
- PATHWORK DIAGNOSTICS TISSUE OF ORIGIN TEST
- Applicant
- Pathwork Diagnostics, Inc.
- Decision
- Unknown
- Date received
- 2008-03-31
- Decision date
- 2008-07-30
- Days to decision
- 121 days
- Clearance type
- Traditional
- Product code
- OIW
- Device class
- 2
- Regulation number
- 862.3100
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Sunnyvale, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Pathwork Diagnostics
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Tissue of Origin Test Kit-FFPE (K173839) | Cancer Genetics, Inc. | 2018-03-15 |
| TISSUE OF ORIGIN TEST KIT FFPE (K120489) | Pathwork Diagnostics, Inc. | 2012-05-17 |
| PATHWORK TISSUE OF ORIGIN TEST KIT-FFPE (ORIGIN TEST KIT-FFPE (K092967) | Pathwork Diagnostics | 2010-06-08 |
Recalls involving this device
No recalls on record reference this clearance.